Why it was recalled
Subpotent and Presence of Particulates .
Product description
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96
Lot numbers, UPCs & expiration codes
Lot # 10009, exp. date 03/2022 10006, exp. date 01/2022
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0391-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 7, 2021
- FDA report date
- May 26, 2021
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0391-2021, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87922
- Address
- 2 Independence Way
- Code information
- Lot # 10009, exp. date 03/2022 10006, exp. date 01/2022
- Postal code
- 08540-6620
- Report date
- May 26, 2021
- Product type
- Drugs
- Recall number
- D-0391-2021
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Termination date
- Jun 17, 2022
- Reason for recall
- Subpotent and Presence of Particulates .
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- May 7, 2021
- Initial firm notification
- Letter
- Center classification date
- May 20, 2021